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Urgent! Quality Engineer Job Opening In Singapore, Singapore – Now Hiring Quasarmedical
The Quality Engineer is responsible for ensuring the quality and regulatory compliance of medical devices throughout the manufacturing process.
This role involves developing and implementing quality assurance strategies, overseeing production processes, managing product quality, and ensuring adherence to industry standards and regulations.
This includes support for new product transfers.
Controlled Environment (Class 10K/100K cleanroom) and office area.
Authority
Approve process/product-related forms, work instructions, and procedures.
Approve the risk assessment file.
Authorize signing the Certificate of Analysis.
Responsibilities
Quality Assurance and Control:
Develop, implement, and maintain quality assurance plans, procedures, and control measures.
Monitor and analyze production processes to detect and resolve quality issues.
Ensure compliance with relevant regulatory requirements, including FDA, ISO 13485, and other applicable standards.
Support internal and external audits and regulatory inspections.
Investigate and resolve product-related issues, deviations, and non-conformities, with the authority to recommend corrective and preventive actions.
Ensure non-conformance or quality issues are resolved in a timely manner.
Participate in new product introductions to ensure quality is built into products early in their lifecycle.
Support validation processes including IQ, OQ, PQ, process validation, and test method validation.
Process Improvement:
Identify opportunities for process improvements to enhance product quality and manufacturing efficiency.
Lead and drive QA initiatives across the product areas.
Lead or participate in root cause analysis and corrective action planning.
Support and drive cost improvement projects.
Customer Interaction:
Address customer complaints and feedback related to product quality.
Work closely with customers to understand their quality requirements and ensure products meet specifications.
Communicate any potential process change requests to customers.
Provide technical support and quality-related information to customers.
Documentation and Reporting:
Maintain comprehensive records of quality control activities, inspection results, and non-conformance reports.
Prepare and support monthly/annual quality reports to management and stakeholders.
Ensure proper documentation and traceability throughout the manufacturing process.
Training and Development:
Train manufacturing staff on quality standards, procedures, and best practices.
Promote a culture of quality and continuous improvement within the organization.
Requirements
Degree in Engineering or science, with 2–5 years of progressive quality responsibility, preferably in medical device/pharmaceutical manufacturing.
Diploma holders in Engineering or science with more than 5 years of experience in Quality may be considered.
Knowledge of regulatory requirements and quality standards, including FDA regulations and ISO 13485 standards.
Good command of the English language.
Strong analytical and problem-solving skills with the ability to troubleshoot complex issues.
Effective collaboration with cross-functional teams and clear presentation of information.
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Unlock Your Quality Engineer Potential: Insight & Career Growth Guide
Real-time Quality Engineer Jobs Trends in Singapore, Singapore (Graphical Representation)
Explore profound insights with Expertini's real-time, in-depth analysis, showcased through the graph below. This graph displays the job market trends for Quality Engineer in Singapore, Singapore using a bar chart to represent the number of jobs available and a trend line to illustrate the trend over time. Specifically, the graph shows 32559 jobs in Singapore and 27925 jobs in Singapore. This comprehensive analysis highlights market share and opportunities for professionals in Quality Engineer roles. These dynamic trends provide a better understanding of the job market landscape in these regions.
Great news! Quasarmedical is currently hiring and seeking a Quality Engineer to join their team. Feel free to download the job details.
Wait no longer! Are you also interested in exploring similar jobs? Search now: Quality Engineer Jobs Singapore.
An organization's rules and standards set how people should be treated in the office and how different situations should be handled. The work culture at Quasarmedical adheres to the cultural norms as outlined by Expertini.
The fundamental ethical values are:The average salary range for a Quality Engineer Jobs Singapore varies, but the pay scale is rated "Standard" in Singapore. Salary levels may vary depending on your industry, experience, and skills. It's essential to research and negotiate effectively. We advise reading the full job specification before proceeding with the application to understand the salary package.
Key qualifications for Quality Engineer typically include Other General and a list of qualifications and expertise as mentioned in the job specification. Be sure to check the specific job listing for detailed requirements and qualifications.
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Here are some tips to help you prepare for and ace your job interview:
Before the Interview:To prepare for your Quality Engineer interview at Quasarmedical, research the company, understand the job requirements, and practice common interview questions.
Highlight your leadership skills, achievements, and strategic thinking abilities. Be prepared to discuss your experience with HR, including your approach to meeting targets as a team player. Additionally, review the Quasarmedical's products or services and be prepared to discuss how you can contribute to their success.
By following these tips, you can increase your chances of making a positive impression and landing the job!
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